Minimal-access percutaneous and self-retracting surgical system

ABSTRACT

Disclosed herein are embodiments of a minimally-invasive surgical system and methods of use which can mimic a mosquito proboscis to efficiently penetrate tissue. The delivery system can utilize a plurality of modular strut instruments to create a working tissue canopy and apply any number of surgical actions to a target tissue.

INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/969,176, filed on May 2, 2018. U.S. patent application Ser. No.15/969,176 claims the benefit of U.S. Application No. 62/500,813, filedMay 3, 2017, titled “MINIMAL-ACCESS PERCUTANEOUS AND SELF-RETRACTINGSURGICAL SYSTEM,” the entirety of which is incorporated herein byreference.

BACKGROUND Field

Embodiments of the disclosure relate to modular surgical systems andmethods of use for performing any of a number of procedures on a targettissue.

Description of the Related Art

Minimally-invasive, robotic, and endoscopic surgery are rapidly evolvingdisciplines that depend to a significant extent on optical andinstrument miniaturization and maneuverability. The ability to performminimally-invasive operations via increasingly small natural corridors,surgical ports, keyhole approaches, and percutaneous access points isincreasing, and remains heavily dependent on existing and emergingtechnology. An inherent obstacle associated with current workingparadigms for surgical target visualization and modular end effectormanipulation is the ability to operate within soft tissue, vis-a-vis anair or fluid medium.

SUMMARY OF THE INVENTION

Embodiments of the present disclosure are directed to a surgical systemsand devices and methods of use. The present disclosure includes, but isnot limited to, the following numbered embodiments.

Embodiment 1

A multi-functional surgical system comprising an outer sheath having aproximal end, a distal end, and a lumen extending between the proximalend and the distal end, an inner module located within the lumen of theouter sheath, the inner module comprising a plurality of lumensextending from a proximal end to a distal end of the inner module, atleast one labrum extending through at least one of the plurality oflumens of the inner module and configured to extend out the distal endof the outer sheath, wherein the at least one labrum is configured topenetrate tissue and to move from a radially closed position to aradially open position, and wherein the at least one labrum isconfigured to withdraw into the inner module, and a plurality of struts,each of the plurality of struts extending through one of the pluralityof lumens of the inner module, wherein the plurality of struts areconfigured to radially expand as they are advanced distally from thedistal end of the outer sheath to form a canopy working area and tocircumferentially move tissue, wherein at least some of the plurality ofstruts comprise a surgical end tip having a surgical function.

Embodiment 2

The multi-functional surgical system of Embodiment 1, wherein the outersheath and the inner module are flexible.

Embodiment 3

The multi-functional surgical system of any one of Embodiments 1-2,further comprising a camera or endoscope extending through one of theplurality of lumens of the inner module.

Embodiment 4

The multi-functional surgical system of any one of Embodiments 1-3,further comprising a hub and relay connected to a processor with a humanor robotic interface.

Embodiment 5

The multi-functional surgical system of any one of Embodiments 1-4,further comprising a power source connected to at least one of thesurgical end tips.

Embodiment 6

The multi-functional surgical system of any one of Embodiments 1-5,wherein the plurality of struts are configured to form a grasping clawwhile being withdrawn into the outer sheath.

Embodiment 7

The multi-functional surgical system of any one of Embodiments 1-6,wherein the at least one labrum comprises a pair of legs each having acutting surface and a needle.

Embodiment 8

The multi-functional surgical system of any one of Embodiments 1-7,wherein the surgical end tips comprise one or more of a micrograspingforcep, a microscissors, a navigation actuator, a microdissector, acautery instrument, a suction device, a vessel clip, a ligationinstrument, a drug delivery device, an ultrasonic or microdoppler flowprobe, and a spectroscopy probe.

Embodiment 9

The multi-functional surgical system of any one of Embodiments 1-8,wherein at least a portion of the at least one labrum is configured tovibrate.

Embodiment 10

The multi-functional surgical system of any one of Embodiments 1-9,wherein the system is bendable and steerable.

Embodiment 11

The multi-functional surgical system of any one of Embodiments 1-10,wherein each of the end tips is configured to longitudinally retract andextend within a lumen of one of the plurality of struts.

Embodiment 12

The multi-functional surgical system of any one of Embodiments 1-11,wherein each of the plurality of struts comprises a bend, the benddirecting the strut from extending radially outward to extendingradially inwards.

Embodiment 13

The multi-functional surgical system of Embodiment 12, wherein the bendcomprises a hinge configured to change angles.

Embodiment 14

The multi-functional surgical system of any one of Embodiments 1-13,wherein some of the plurality of struts do not have a surgical end tip.

Embodiment 15

A method of performing surgery comprising advancing a multi-functionalsurgical system having an outer sheath to a target location with atarget tissue, the advancing comprising cutting through tissue with atleast one labrum of the surgical system to enter the target location,the at least one labrum extending through a lumen of the outer sheathand out a distal end of the outer sheath, distally advancing a pluralityof struts through the outer sheath and into the target location, whereinthe plurality of struts radially expand as they are distally advancedout of the outer sheath to form a canopy working area around the targettissue, and wherein at least some of the plurality of struts includes anend effector, and performing an action on the target tissue using atleast one of the end effectors of the plurality of struts.

Embodiment 16

The method of Embodiment 15, wherein the performing the action comprisescutting, cauterizing, dissection, clipping, ligation, drug delivery,suction, removal, or grasping.

Embodiment 17

The method of any one of Embodiments 15-16, wherein the surgical systemis controlled robotically.

Embodiment 18

The method of any one of Embodiments 15-17, further comprisingretracting the at least one labrum into the outer sheath prior to orsimultaneously while distally advancing the plurality of struts.

Embodiment 19

The method of any one of Embodiments 15-18, further comprisingwithdrawing the plurality of struts after performing the action, whereinthe withdrawing comprises radially compressing the plurality of strutsto grasp the target tissue and translate the target tissue towards theouter sheath.

Embodiment 20

A surgical system comprising an outer sheath, a first plurality ofstruts positioned within or attached to the outer sheath, the firstplurality of struts comprising sharp tips that form a unified tissuedissector, the unified tissue dissector configured to penetrate intotissue and radially open and close to cut and retract tissue radiallyoutwardly to facilitate advancement of the surgical system through softtissue, and a second plurality of struts configured to be advanced fromwithin the outer sheath, the second plurality of struts expandingradially when distally advanced from the outer sheath to form aretraction canopy around a surgical target site, wherein at least someof the second plurality of struts comprise working instrumentsconfigured to perform a function at the surgical target site.

Embodiment 21

The surgical system of Embodiment 20, wherein the second plurality ofstruts is configured to form a grasping claw when withdrawn into theouter sheath.

Embodiment 22

The surgical system of any one of Embodiments 20-21, further comprisinga hub and relay to connect one or more struts to a processor and humanor robotic interface.

Embodiment 23

The surgical system of any one of Embodiments 20-22, wherein the firstplurality of struts comprises a pair of labrums and an inner needle.

Embodiment 24

The surgical system of Embodiment 23, wherein the second plurality ofstruts comprise strut instruments interspersed with the pair of labrumsand inner needle.

Embodiment 25

The surgical system of any one of Embodiments 20-24, wherein the unifiedtissue dissector is configured to retract tissue as the outer sheathdocks proximal to the surgical site.

Embodiment 26

The surgical system of any one of Embodiments 20-25, wherein the secondplurality of struts are configured to advance from within the outersheath as the tissue dissector is withdrawn into the outer sheath.

Embodiment 27

The surgical system of any one of Embodiments 20-26, further comprisinga camera or endoscope positionable within the outer flexible sheath.

Embodiment 28

The surgical system of any one of Embodiments 20-27, wherein the workinginstruments comprise one or more a micrograsping forceps, amicroscissors, a microdissector, a cautery instrument, a suction device,a vessel clip, a ligation instrument, a drug delivery device, anultrasonic or microdoppler flow probe, and a spectroscopy probe.

Embodiment 29

The surgical system of any one of Embodiments 20-28, further comprisinga power source connected to at least one of the working instruments.

Embodiment 30

The surgical system of any one of Embodiments 20-29, wherein the firstplurality of struts comprises a pair of legs and a needle.

Embodiment 31

The surgical system of any one of Embodiments 20-30, wherein at least aportion of the tissue dissector is configured to vibrate.

Embodiment 32

The surgical system of any one of Embodiments 20-31, wherein the outersheath is bendable and steerable.

Embodiment 33

The surgical system of any one of Embodiments 20-32, wherein each of theworking instruments is configured to longitudinally retract and extendwithin a lumen of one of the second plurality of struts.

Embodiment 34

The surgical system of any one of Embodiments 20-33, wherein each of thesecond plurality of struts comprises a bend, the bend directing thestruts from extending radially outward to extending radially inwards.

Embodiment 35

The surgical system of Embodiment 34, wherein the bend comprises a hingeconfigured to change angles.

Embodiment 36

The surgical system of any one of Embodiments 20-35, wherein some of thesecond plurality of struts do not have working instrument.

Embodiment 37

The surgical system of any one of Embodiments 20-36, wherein the firstplurality of struts are configured to cut and retract tissue radiallyoutwards to facilitate advancement of the system through tissue.

Embodiment 38

A method of using the surgical system of any one of Embodiments 20-37,the method comprising advancing the surgical system to a target locationwithin a target tissue, the advancing comprising cutting through tissuewith the tissue dissector to enter the target location, distallyadvancing the second plurality of struts through the outer sheath andinto the target location, where the second plurality of struts radiallyexpand as they are distally advanced out of the outer sheath to form theretraction canopy around the target tissue, and performing the functionon the target tissue using the working instruments.

Embodiment 39

An assembly for a surgical system, the assembly comprising a firstsurgical device comprising at least one labrum at a distal endconfigured to penetrate tissue and to move from a radially closedposition to a radially open position, and a second surgical devicecomprising a plurality of struts, each of the plurality of struts beingconfigured to radially expand as they are advanced distally to form acanopy working area, wherein at least some of the plurality of innerstruts comprise an end tip having surgical functionality.

Embodiment 40

The method of Embodiment 39, the method comprising advancing the firstsurgical device near to a target tissue to form a tunnel, withdrawingthe first surgical device through the tunnel, advancing the secondsurgical device through the tunnel, distally and radially extending theplurality of struts of the second surgical device to form the canopyworking area, and performing a surgical operation with at least one ofthe end tips.

Embodiment 41

A surgical system comprising an outer flexible sheath, a first pluralityof struts positioned within or attached to the outer flexible sheath,the first plurality of struts having sharp tips that together form aunified tissue dissector, the tissue dissector having an advancedposition for penetrating into tissue and a retracted position in whichthe first plurality of struts are configured to retract tissue radiallyoutwardly, and a second plurality of struts advanceable from within theouter flexible sheath, the second plurality of struts being expandableradially when advanced from the outer flexible sheath to form a canopyaround a surgical site, wherein at least some of the second plurality ofstruts comprise working instruments configured to perform a function atthe surgical site.

Embodiment 42

The surgical system of Embodiment 41, wherein the second plurality ofstruts is configured to form a grasping claw when withdrawn into theouter sheath.

Embodiment 43

The surgical system of any one of Embodiments 41-42, further comprisinga hub and relay to connect one or more struts to a processor and humanor robotic interface.

Embodiment 44

The surgical system of any one of Embodiments 41-43, wherein the firstplurality of struts comprises a pair of labrums and an inner needle.

Embodiment 45

The surgical system of Embodiment 44, wherein the second plurality ofstruts comprise strut instruments interspersed with the pair of labrumsand inner needle.

Embodiment 46

The surgical system of any one of Embodiments 41-45, wherein the unifiedtissue dissector is configured to retract tissue as the outer sheathdocks proximal to the surgical site.

Embodiment 47

The surgical system of any one of Embodiments 41-46, wherein the secondplurality of struts are configured to advance from within the outersheath as the tissue dissector is withdrawn into the outer sheath.

Embodiment 48

The surgical system of any one of Embodiments 41-47, further comprisinga camera or endoscope positionable within the outer flexible sheath.

Embodiment 49

The surgical system of any one of Embodiments 41-48, wherein the workinginstruments comprise one or more a micrograsping forceps, amicroscissors, a microdissector, a cautery instrument, a suction device,a vessel clip, a ligation instrument, a drug delivery device, anultrasonic or microdoppler flow probe, and a spectroscopy probe.

Embodiment 50

The surgical system of any one of Embodiments 41-49, further comprisinga power source connected to at least one of the working instruments.

Embodiment 51

The surgical system of any one of Embodiments 41-50, wherein the firstplurality of struts comprises a pair of legs and a needle.

Embodiment 52

The surgical system of any one of Embodiments 41-51, wherein at least aportion of the tissue dissector is configured to vibrate.

Embodiment 53

The surgical system of any one of Embodiments 41-52, wherein the outersheath is bendable and steerable.

Embodiment 54

The surgical system of any one of Embodiments 41-53, wherein each of theworking instruments is configured to longitudinally retract and extendwithin a lumen of one of the second plurality of struts.

Embodiment 55

The surgical system of any one of Embodiments 41-54, wherein each of thesecond plurality of struts comprises a bend, the bend directing thestruts from extending radially outward to extending radially inwards.

Embodiment 56

The surgical system of Embodiment 55, wherein the bend comprises a hingeconfigured to change angles.

Embodiment 57

The surgical system of any one of Embodiments 41-56, wherein some of thesecond plurality of struts do not have working instrument.

Embodiment 58

The surgical system of any one of Embodiments 41-57, wherein the firstplurality of struts are configured to cut and retract tissue radiallyoutwards to facilitate advancement of the system through tissue.

Embodiment 59

A method of using the surgical system of any one of Embodiment 41-58,the method comprising advancing the surgical system to a target locationwithin a target tissue, the advancing comprising cutting through tissuewith the tissue dissector to enter the target location, distallyadvancing the second plurality of struts through the outer sheath andinto the target location, where the second plurality of struts radiallyexpand as they are distally advanced out of the outer sheath to form theretraction canopy around the target tissue, and performing the functionon the target tissue using the working instruments.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates an embodiment of the surgical device with the labrumin a radially closed position.

FIG. 2 illustrates a schematic head-on view of an embodiment of thesurgical device with the labrum in a radially closed position and withcertain structurers omitted for convenience.

FIG. 3 illustrates an embodiment of the surgical device with the labrumin a radially open position.

FIG. 4 illustrates an embodiment of the surgical device with the labrumlongitudinally retracted and the struts longitudinally extended to forma canopy.

FIG. 5 illustrates an embodiment of the surgical device with the labrumlongitudinally retracted and the struts longitudinally extended to forma canopy.

FIG. 6 illustrates an embodiment of the end effectors of the strutsdistally extended.

FIG. 7 illustrates an embodiment of the end effectors of the strutsdistally extended.

FIG. 8 illustrates a head on view of an embodiment of the surgicaldevice.

FIG. 9 illustrates a cross-section of an embodiment of the surgicaldevice.

FIGS. 10A and 10B illustrate schematic examples of distal end ofembodiments of a surgical device with certain structurers omitted forconvenience.

FIG. 11 illustrates a schematic example of a distal end of an embodimentof the surgical device showing the formation of the working canopy withcertain structurers omitted for convenience.

FIGS. 12-18 illustrate an example method of use of an embodiment of thedisclosed surgical device.

DETAILED DESCRIPTION

Disclosed herein are embodiments of minimally-invasive devices, systemsand methods to facilitate a number of operations located throughout thebody based on principles derived from and designed to mimic a mosquitoproboscis targeting a blood vessel, adapted to facilitate access to asurgical target for any number of surgical indications. Specifically,embodiments described herein are directed to a device and systemdesigned to access a surgical target and operate within the human bodyin a soft tissue, air or fluid medium. The device and system maycomprise a variety of interchangeable, modular instruments and providetargeted, minimally-invasive access and visualization via acircumferential retractor and dissector. The dissector may mimic amosquito proboscis, thus accessing a target site while minimallydisrupting tissue along the way. Further, the retraction can maximizevisualization and workplace clearance for operating.

Embodiments of the device may be used to 1) achieve percutaneous orminimally-invasive “keyhole” access, 2) maneuver towards a surgicaltarget with minimal tissue disruption through a soft tissue, air orfluid medium, 3) dilate and circumferentially retract soft tissueproximal to the surgical target to improve visualization and surgicalmanipulation, and 4) perform a number of surgical maneuvers includingcutting, grasping, cautery, tissue resection/biopsy, ligation, clipping,and drug delivery, among others.

FIG. 1 illustrates an embodiment of the surgical device (e.g., surgicalsystem, system, assembly, or device) 100. As shown, the device 100 caninclude an outer sheath 102 configured for maneuvering in tissues, suchas in tissue of a patient. In some embodiments, the outer sheath 102 maybe a flexible. In some embodiments, the outer sheath 102 may besemi-rigid. In some embodiments, the outer sheath 102 may be rigid. Theparticular rigidity does not limit the disclosure. In some embodiments,the outer sheath 102 can be straight. In some embodiments, the outersheath 102 may be curved. In some embodiments, the outer sheath 102 mayhave one or more curves. The outer sheath 102 may be metal (such asaluminum, titanium, Nitinol), plastic, rubber, etc. and the materialdoes not limit the disclosure. The outer sheath may be biocompatible.

In some embodiments, the outer sheath 102 may have an outer diameter of15, 14, 13, 12, 11, 10, 9, 8, 7, 6, or 5 mm. In some embodiments, theouter sheath 102 may have an outer diameter of greater than 15, 14, 13,12, 11, 10, 9, 8, 7, 6, or 5 mm. In some embodiments, the outer sheath102 may have an outer diameter of less than 15, 14, 13, 12, 11, 10, 9,8, 7, 6, or 5 mm. In some embodiments, the outer sheath 102 may have aninner diameter of 15, 14, 13, 12, 11, 10, 9, 8, 7, 6, or 5 mm. In someembodiments, the outer sheath 102 may have an inner diameter of greaterthan 15, 14, 13, 12, 11, 10, 9, 8, 7, 6, or 5 mm. In some embodiments,the outer sheath 102 may have an inner diameter of less than 15, 14, 13,12, 11, 10, 9, 8, 7, 6, or 5 mm. The outer sheath 102 may have a lumenextending longitudinally through it from a proximal end (e.g., near theoperator) to the distal end (e.g., the end portion shown in FIG. 1).

In some embodiments, the device 100 may have a length of about 10, 11,12, 13, 14, 15, 16, 17, 18, 19, or 20 cm. In some embodiments, thedevice 100 may have a length of greater than about 10, 11, 12, 13, 14,15, 16, 17, 18, 19, or 20 cm. In some embodiments, the device 100 mayhave a length of less than about 10, 11, 12, 13, 14, 15, 16, 17, 18, 19,or 20 cm.

In some embodiments, the device 100 may have a length of 10, 20, 30, 40,50, 60, 70, 80, 90, or 100 cm. In some embodiments, the device 100 mayhave a length of greater than 10, 20, 30, 40, 50, 60, 70, 80, 90, or 100cm. In some embodiments, the device 100 may have a length of less than10, 20, 30, 40, 50, 60, 70, 80, 90, or 100 cm.

Within the lumen, the device 100 may include an inner module 200. Insome embodiments, the device 100 may not include an inner module. Theinner module 200 can be concentrically aligned within the lumen of theouter sheath 102 to fit within and pass through the outer sheath 102. Insome embodiments, the inner module 200 may have an outer diameter of 15,14, 13, 12, 11, 10, 9, 8, 7, 6, or 5 mm. In some embodiments, the innermodule 200 may have an outer diameter of greater than 15, 14, 13, 12,11, 10, 9, 8, 7, 6, or 5 mm. In some embodiments, the inner module 200may have an outer diameter of less than 15, 14, 13, 12, 11, 10, 9, 8, 7,6, or 5 mm. The inner module 200 outer surface may abut the innersurface of the outer sheath 102. The inner module 200 may be attached toan inner surface of the outer sheath 102. In some embodiments, the innermodule 200 can translate relative to the outer sheath 102. In someembodiments, the inner module 200 stays connected to the outer sheath102. The inner module 200 may contain a number of lumens extendingthrough which hold the different components discussed below. The lumensmay extend from a distal end to a proximal end of the inner module 200.The inner module 200 may extend the entire length of the device 100. Insome embodiments, the inner module 200 may extend less than the entirelength of the device 100. The inner module 200 may be a flexible casing.The inner module 200 may be made of a flexible material so as to bendwith the device 100 and prevent any damage to the components within theinner module 200. The inner module 200 may be plastic, polymer, rubber,metal, and the type of material is not limiting.

The inner module 200 may contain a number of different components, suchas disclosed herein. In some embodiments, all of the below-listedcomponents are included. In some embodiments, only some of thebelow-listed components are used.

In some embodiments, the inner module 200 can include one or moreflexible suction cannulae (for example 2 mm diameter). In someembodiments, the inner module 200 can include a proximally situated hubor port for electrical wiring (for example 2 mm diameter). In someembodiments, the inner module 200 can include a port for irrigation ordrug delivery (for example 1 mm diameter). In some embodiments, theinner module 200 can include a fiberoptic light source. In someembodiments, the inner module 200 can include a distal end (actuator)designed to interface with currently existing navigation, stereotactic,or robotic interfaces to provide the end user with informationpertaining to the location of the distal end on an imaging study (forexample 1 mm diameter). In some embodiments, the inner module 200 caninclude an ultrasonic probe or camera (for example 2 mm diameter). Any,some, or all of the above listed components can be included in thedevice 100.

In some embodiments, the inner module 200 may include a camera/flexibleendoscope/visualization device 202. The visualization device 202 caninclude, for example, a lens/aperture. This visualization device 202 canbe used to provide an operator a view of the distal end of the device200 at an externally located monitor (e.g., computer screen, laptop,smart phone). The visualization device 202 may be directly connected toan externally located monitor and/or power source. The visualizationdevice 202 may be wirelessly connected to an externally located monitorand/or power source. In some embodiments, the visualization device 202can be flexible, semi-rigid, or rigid. As shown, the visualizationdevice 202 can extend through the lumen of the outer sheath 102. In someembodiments, the visualization device 202 can extend fully or partiallythe length of the outer sheath 102. In some embodiments, thevisualization device 202 can have a diameter of 5, 4, 3, 2, or 1 mm. Insome embodiments, the visualization device 202 can have a diameter oflarger than 5, 4, 3, 2, or 1 mm. In some embodiments, the visualizationdevice 202 can have a diameter of smaller than 5, 4, 3, 2, or 1 mm. Insome embodiments, the device 100 may not include a visualization device202. In some embodiments, the visualization device 202 can extend thefull length of the device 100. In some embodiments, the visualizationdevice 202 may extend distal the outer sheath 102. In some embodiments,the visualization device 202 may be recessed proximal to the distal endof the outer sheath 102. In some embodiments, the visualization device202 can be steered, thereby steering the device 100. In someembodiments, the visualization device 202 can have an adjacentmicro-irrigation port (such as extending through the inner module 200)to provide irrigation of the lens if it should become obscured due tosurgical byproducts such as blood, smoke, tissue or fluid.

In some embodiments, the outer sheath 102 may be actively steered by auser or a robotic interface. In some embodiments, the outer sheath maybe passively driven by steering of another portion of the device. Forexample, the visualization device 202 may be steered in someembodiments. In some embodiments, the inner module 200 may be steered.The outer sheath 102 may experience 1, 2, 3, 4, 5, or 6 bends duringsteering.

In some embodiments, the inner module 200 can include a labrum (e.g.,tissue dissector, proboscis, first plurality of struts) 300. The labrum300 can be advantageous for penetrating tissue, specifically for makinga minimal-access percutaneous insertion of the device 100 and continuedadvancement through tissue. Thus, the labrum 300 can generally reducedamage to the patient when inserting and maneuvering the device 100. Forexample, the labrum 300 can be designed to penetrate skin and/or softtissue such as brain, muscle, fat, lung, liver, etc. while causinglimited damage.

The labrum 300 can in some embodiments comprise a pair of legs 302 and aneedle 304 (e.g., collectively a first plurality of struts), as shown inFIG. 1, each extending through separate (or the same) lumens in theinner module 200. In some embodiments, the labrum 300 can include onlyone of pair of legs 302 (e.g., each leg can be a labrum and thus thepair of legs 302 can be a pair of labrums) or the needle 304. In someembodiments, the labrum 300 can collectively include the pair of legs302 and the needle 304. In some embodiments, the labrum 300 cancollectively include the pair of legs 302. The legs 302 and needle 304can have sharp tips that together (either just the pair of legs 302 orthe pair of legs 302 with the needle 304) form a unified tissuedissector in some embodiments. The legs 302 can include a cutting edge306 at their distal end. The cutting edge 306 can be curved in someembodiments. The cutting edge 306 can be straight in some embodiments.The legs 302 can be generally shaped like a rectangular prism, thoughthe particular shape of the legs 302 are not limiting. The needle 304can include a distal tip 308.

In some embodiments, the needle 304 can come to a point. In someembodiments, the needle 304 can include a dual bevel. In someembodiments, the needle 304 can be hollow. In some embodiments, theneedle 304 can extend further distally than the legs 302, and thus actas the initial cut/penetration point when advancing the device 100. Insome embodiments, the needle 304 may not be used. In some embodiments,three legs 302 can be used where one leg can replace the needle 304. Insome embodiments, one leg 304 may be used with the needle 304. In someembodiments, 3, 4, 5, or 6 legs can be used.

The labrum 300 (e.g., the legs 302 and the needle 304) can be configuredto radially open and close in some embodiments. Thus, the labrum 300 maybe configured to retract tissue radially outwards as the labrum 300radially opens. In some embodiments, the legs 302 and/or the needle 304may have straight or serrated side edges for cutting through tissues.

In some embodiments, the labrum 300 can longitudinally retract andextend from the inner module 200 and/or the outer sheath 102. In someembodiments, the labrum 300 can both radially open and close and canlongitudinally retract and extend.

When advanced, the labrum 300 can facilitate maneuverability andnavigable docking of the outer sheath 102 edge on a surgical target,that may be visualized via a camera or endoscope (such as visualizationdevice 202) on the distal end and possibly predetermined or preplannedon imaging studies correlated to the navigation system and a distal endactuator to provide 3D stereotactic location data, or via ultrasonic orDoppler flow probe guidance to target blood vessels. The labrum 300 mayalso be equipped with individual actuators or sensors to relaythree-dimensional stereotactic information pertaining to instrument tiplocation and function to a processor or robot located outside the body.

FIG. 2 illustrates a schematic example of device 100 showing relativedistalmost positions of certain components within the device 100.Certain structural elements (and portions of other shown structuralelements) are omitted for convenience. Thus, the particular shape of thedevice 100 and related components shown in FIG. 2 is not limiting.

FIG. 2 shows a distal end of the device 100 when the labrum 300 is inthe radially closed position. As shown, the needle 304 can be generallyat the center of the lumen of the outer sheath 102. The two legs 302 canbe located on opposite sides of the needle 304. In some embodiments, theneedle 304 and legs 302 extend longitudinally straight out of the outersheath 102 such as shown in FIG. 2. In some embodiments, the needle 304and legs 302 can extend out of the sheath 102 at an angle and meetgenerally at the center of the diameter of the outer sheath 102, such asshown in FIG. 1. For example, the needle 304 can extend from a topportion of the outer sheath 102 and the legs can extend from the leftand right portions of the outer sheath 102. In some embodiments, theneedle 304 and the legs 302 are spaced approximately 60° apart. When thelabrum 300 is in the radially closed position, the visualization device202 may be partially blocked by the needle 304, the legs 302, or bothfor a user.

FIG. 3 shows the device 100 having the labrum 300 in the radially openposition. As shown, the needle 304 and the legs 302 radially rotatesoutwards (e.g., from the center of the outer sheath 102 towards theedges). In some embodiments, the needle 304 and the legs 302 extendgenerally straight in the radially open position. In some embodiments,the needle 304 and the legs 302 extend at an outward angle from thecenter of the outer sheath 102. When the labrum 300 is in the radiallyopen position, the visualization device 202 may be unblocked for a user.

In some embodiments, the needle 304 and the legs 302 can be collectivelymoved between the radially open and radially closed position. In someembodiments, the needle 304 and the legs 302 can be independently movedbetween the radially open and the radially closed position. This radialopening and closing can allow for the labrum 300 to cut through tissuesas the device 100 moves forward in tissue. For example, the radiallyopening can spread tissue, and the legs 302 can include sharp edges orserrated edges to cut through the tissue, allowing the device 100 toadvance. Further, in some embodiments, the labrum 300 (for example thelegs 302 and/or the needle 304) can vibrate, which can improve thecutting through the tissue. In some embodiments, the labrum 300 isconstantly radially opening and closing as the device 100 is advanced.The labrum 300 can have an advanced position for penetrating tissue(e.g., the closed position) and a radially expanded position in whichthe labrum 300 is configured to cut and retract tissue radiallyoutwardly to facilitate advancement of the device 100 through softtissue.

The labrum 300 can be longitudinally retracted/extended in someembodiments. FIGS. 1 and 3 illustrate the labrum 300 in thelongitudinally extended position so that the labrum 300 extends distallyfrom the outer sheath 102. The labrum 300 can then be longitudinallyretracted into the outer sheath 102. In some embodiments, the labrum 300can fully enter the outer sheath 102 upon retraction. In someembodiments, a portion of the labrum 300 can still extend from thedistal end of the outer sheath 102 after retraction.

In some embodiments, the needle 304 and the legs 302 can be individuallycollectively retracted/extended. In some embodiments, the needle 304 andthe legs 302 can be independently longitudinally retracted/extended.

While the above discusses the legs 302 and needle 304 located within theinner module 200, in some embodiments, the legs 302 and needle 304 maybe attached to the outer sheath 102 (such as at an inner circumferenceor an outer circumference).

The inner module 200 can further comprise a plurality of struts (e.g.,strut instruments, arms, legs, canopy portions, second plurality ofstruts) that can be longitudinally retracted into the outer sheath 102and longitudinally extended distal the outer sheath 102. FIGS. 1 and 3show the struts retracted into the inner module 200 and FIGS. 4-7illustrate the struts extended longitudinally outwards. The struts canbe fully retracted into the inner module 200 and/or outer sheath 102 insome embodiments.

As shown in FIG. 4, the struts 402 can end at a distal tip 404. Thedistal tip 404 may be atraumatic in some embodiments. The distal tip 404may have a cutting surface in some embodiments. The distal tip 404 mayhave a gripping surface in some embodiments. Further, the needle 304 andlegs 302 are shown to be withdrawn at least partially into the innermodule 200. The struts 402 can extend from an outer circumference of theinner module 200, for example through lumens longitudinally extendingthrough the inner module 200. The struts 402 can be expandable, hinged,and rigid or semi-rigid in some embodiments.

The number of struts 402 extending from the inner module 200 can vary.For example, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 struts 402 can be used. Insome embodiments, greater than 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 struts402 can be used. In some embodiments, less than 2, 3, 4, 5, 6, 7, 8, 9,or 10 struts 402 can be used. In some embodiments, the device 100 cancontain 6-8 instruments. In some embodiments, the device 100 can contain3-5 instruments.

In some embodiments, the struts 402 may all be identical (or generallyidentical) in size/shape. In some embodiments, the struts 402 may varyin shape. In some embodiments, every other strut 402 may have adifferent shape. In some embodiments, half of the struts 402 may haveone particular shape and half may have a different shape. In someembodiments, all of the struts 402 can extend the same longitudinaldistance out of the inner module 200. In some embodiments, some struts402 may extend a different longitudinal distance than other struts 402.In some embodiments, the struts 402 can be individually extended. Insome embodiments, the struts 402 are collectively extended at the sametime. In some embodiments, the longitudinal distance of the struts 402can be varied by a user.

As shown in FIGS. 4-5, the struts 402 can extend from the inner module200 at an outward angle (e.g., towards the outer sheath 102). Further,the struts 402 may include a bend 406 (e.g., elbow, hinge, curve, angle)to direct the distal tips 404 of the struts 402 outwards radially yetlongitudinally aligned with the longitudinal axis of the outer sheath102 or can be angled inwards towards the center of the outer sheath 102.The bend 406 can help form the canopy discussed below.

In some embodiments, the struts 402 can extend from the inner module200, as compared to a longitudinal axis of the outer sheath 102, at 25,30, 35, 40, 45, or 50° angle. In some embodiments, the struts 402 canextend from the inner module 200, as compared to a longitudinal axis ofthe outer sheath 102, at greater than a 25, 30, 35, 40, 45, or 50°angle. In some embodiments, the struts 402 can extend from the innermodule 200, as compared to a longitudinal axis of the outer sheath 102,at less than a 25, 30, 35, 40, 45, or 50° angle. In some embodiments,the struts 402 may have a variable angle extending from the inner module200 as manipulated by a user.

In some embodiments, the bend or hinge 406 can provide for a 25, 30, 35,40, 45, or 50° angle between a distal portion 408 and proximal portion410 of the strut 402. In some embodiments, the bend 406 can provide forgreater than a 25, 30, 35, 40, 45, or 50° angle between a distal portion408 and proximal portion 410 of the strut 402. In some embodiments, thebend 406 can provide for a less than 25, 30, 35, 40, 45, or 50° anglebetween a distal portion 408 and proximal portion 410 of the strut 402.In some embodiments, the bend 406 can be manipulated by a user in orderto change the angle between the distal portion 408 and the proximalportion 410.

In some embodiments, the struts 402 may be curved, angled, or straightand may be rigid, semi-rigid, or hinged. In some embodiments, the struts402 may be straight while within lumens in the inner module 200, and maybend once extending distally from the inner module 200. In someembodiments, the angles in the struts 402 can be hinges. In someembodiments, the hinges may be manually or robotically operated. In someembodiments, the struts 402 may be made of a memory saving material, sothat the struts 402 move to a particular configuration upon distalextension from the inner module 200. In some embodiments, the struts 402are compressed in a straight configuration in the inner module 200.

The radially outward angle of the struts 402 along with the bends 406allow for the formation of a working area, work space, retractioncanopy, or canopy working area 500. Specifically, by having the struts402 extend radially outwards from the inner module 200 and then bendback inwards, the struts 402 can push tissue radially away (e.g.,retracting tissue out of the way). Thus forms the canopy 500, which isan area where soft tissue has been displaced. This allows for a workingspace for the end effectors of the struts 402, discussed below, alongwith improved visualization.

The canopy 500 can be formed within tissue, such as within soft tissue.This can include, for example, organs, skin, muscle, etc. Thus, thedevice 100 is not limited to just stretching skin at an outer surface ofa patient. The canopy 500 can extend proximal to a surgical target, thusretracting tissue out of the way of the surgical target site. This canallow for a user to achieve target visualization and provide a workingspace. In some embodiments, when the struts 402 are fully advanced andradially expanded, the working diameter of the canopy 500 can be largerthan the outer sheath 102 or inner module 202. In some embodiments, theworking diameter of the expanded canopy 500 can be 10, 11, 12, 13, 14,or 15 mm. In some embodiments, the working diameter of the expandedcanopy 500 can be greater than 10, 11, 12, 13, 14, or 15 mm. In someembodiments, the working diameter of the expanded canopy 500 can be lessthan 10, 11, 12, 13, 14, or 15 mm. The canopy 500 can simultaneouslyshield the surgical target site from tissue prolapse, settling, and/orblood products, thereby maintaining visualization and access to thesurgical target site.

FIG. 6 illustrates a closer view of a distal end of the device 100. Asshown, the struts 402 can include lumens 450 extending through thestruts and out the distal tips 404. The lumens 450 can hold surgicalinstruments (working instruments, surgical end tips, end tips,micro-instruments, end effectors, etc.) 452. Thus, the surgicalinstruments 452 can be longitudinally retracted into the struts 402 andcan be longitudinally extended distally out of the struts 402. Thus, thesurgical instruments 452 can operate in a self-retracting manner. Thesurgical instruments 452 may be modular or interchangeable. In someembodiments, the surgical instruments 452 can have a diameter of about0.5, 1, 1.5, 2, 2.5, or 3 mm in diameter. In some embodiments, thesurgical instruments 452 can have a diameter of greater than about 0.5,1, 1.5, 2, 2.5, or 3 mm in diameter. In some embodiments, the surgicalinstruments 452 can have a diameter of less than about 0.5, 1, 1.5, 2,2.5, or 3 mm in diameter. In some embodiments, the surgical instruments452 can work in unison. In some embodiments, the surgical instruments452 can work independently. The surgical instruments 452 can converge ona surgical target located near the center of the struts distal ends 404.

In some embodiments, the surgical instruments 452 can extend distally 5,6, 7, 8, 9, 10, 11, 12, 13, 14, or 15 mm from a distal end of the outersheath 102. In some embodiments, the surgical instruments 452 can extenddistally greater than 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, or 15 mm from adistal end of the outer sheath 102. In some embodiments, the surgicalinstruments 452 can extend distally less than 5, 6, 7, 8, 9, 10, 11, 12,13, 14, or 15 mm from a distal end of the outer sheath 102.

Any number of different surgical instruments 452 can be used. Forexample, FIG. 6 shows a suction instrument 454, a cautery instrument(such as a bipolar cautery instrument) 456, and scissors 458. However,other instruments can be used as well, such as, for examplemicrograsping forceps, microscissors, a microdissector, a cauteryinstrument, a suction device, a vessel clip, a ligation instrument, adrug delivery device, an ultrasonic or microdoppler flow probe, and aspectroscopy probe. In some embodiments, not every strut 402 has asurgical instrument 452, such as shown in FIG. 6. In some embodiments,every strut 402 has a surgical instrument 452. In some embodiments, eachsurgical instrument 452 is different. In some embodiments, the struts402 are the surgical instruments themselves (e.g., no lumen extendingthrough the struts 402). In some embodiments, two or more of a certainsurgical instruments 452 can be used. The surgical instruments 452 canbe connected at their proximal end to different devices that can operatethe surgical instruments 452, such as a power source, and electricalsource, a suction source, a mechanical operation source, etc. Thesurgical instruments 452 and struts 402 may include flexible portions tobend along with the device 100.

Designs are contemplated by which circumferentially opposing struts 402and surgical instruments 452 are placed strategically across from eachother to oppose one another within a circular, hexagonal or octagonalarrangement and thereby maintain maximal dilation of tissue. Similarly,the device 100 may be designed to less preferentially have surgicalinstruments 452 which frequently co-function be located adjacent to oneanother.

In some embodiments, the surgical instruments 456 can have modularinstrument functions in any combination of the following: suction device(with or without retractable sharp dissector or knife), single shaftmicro-scissors, single shaft micro-grasping forceps, dissector, curette,drug delivery or irrigation cannula, ultrasonic probe, optical probe forspectroscopy or OCT, vascular clip applier for vessels or aneurysms,ligation devices, monopolar, sesquipolar, or bipolar cautery,endoluminal access device, electrophysiological stimulation probe, drillor ultrasonic curette, ultrasonic aspirator, or side cutting aspirator.Other instruments can be used as well, and the type of instrument is notlimiting. In some embodiments, the surgical instruments 456 can beremoved and replaced for different instruments during a procedure. Insome embodiments, the surgical instruments 456 can be removed andreplaced for different instruments between procedures.

At any time during an operation, the struts 402 and surgical instrument452 can be withdrawn back into the outer sheath 102, and simultaneouslyconverge or collapse back together, thereby forming a grasping “claw”which can be used to trap and remove surgical tissue (e.g., a tumor).The synchronized motion of struts 402 for the formation of a claw may beautomatically controlled robotically.

The surgical instruments 452 can be controlled by a human or robot, andcan be advanced from the outer sheath 102 to expand the canopy 500 anddock on the surgical target.

Each strut 402 and/or surgical instrument 452 may be hinged, motorized,and independently maneuverable via a human or robot to facilitatesurgical manipulation, dissection, cutting, resection or cautery oftissue. Struts 402 and/or surgical instruments 452 may be automaticallycontrolled during manipulation and able to follow trajectories ormaintain regulated fixed positions. In some embodiments, the hinges,bends, or “elbows” of the struts 402 maintain tissue retraction whilethe distal ends simultaneously perform primary surgical functions at thesurgical instruments 452. In some embodiments, information from eachinstrument 452, such as via actuators or additional sensors, may berelayed (via wires or otherwise) back to the proximal robotic device orcentral processing unit, so as to provide information/data includinginstrument location/coordinates, temperature, sensor information fromultrasonic or spectroscopic sensors, haptic feedback, pressure sensors,optical sensors, tissue resistance/pressure, impedance, current, etc.This information may then be integrated into software feedbackalgorithms which can manually, robotically or otherwise automaticallyregulate or control the performance or function of each instrument.

In some embodiments, only some of the struts 402 perform surgicaloperation. Thus, some of the struts 402 (e.g., nonworking struts) remainradially outwards to continue forming the canopy 500 while other struts(e.g., working struts) extend more radially inward to perform theoperation using the surgical instruments 452. The struts with thesurgical instruments 452 may continue forming the canopy 500 in someembodiments. In some embodiments, the struts 402 with the surgicalinstruments 452 may no longer be a part of the canopy, leaving theremaining struts 402 to hold the canopy. In some embodiments, 2, 3, 4,5, 6 struts 402 can be nonworking struts. In some embodiments, greaterthan 2, 3, 4, 5, 6 struts 402 can be nonworking struts. In someembodiments, less than 2, 3, 4, 5, 6 struts 402 can be nonworkingstruts. In some embodiments, 1, 2, 3, 4, 5, 6 struts 402 can be workingstruts. In some embodiments, greater than 1, 2, 3, 4, 5, 6 struts 402can be working struts. In some embodiments, less than 2, 3, 4, 5, 6struts 402 can be working struts.

FIG. 7 illustrates the device 100 and canopy 500 with the surgicalinstruments 452 deployed.

FIG. 8 illustrates a head-on view of the distal end of the device 100.As shown, the inner module 200 can contain a number of lumens 203 forextension of the different components discussed above. For example,there can be a lumen for the legs 302, needle 304, struts 402, andvisualization device 202. The distal end of the lumens 203 can be“sealable” to provide fluid or tissue from entering them. For example,each of the lumens 203 can have a seal over them. FIG. 9 illustrates across-section of the distal end of the device 100.

FIGS. 10A, 10B, and 11 illustrate a schematic example of device 100showing relative distalmost positions of certain components within thedevice 100. Certain structural elements (and portions of other shownstructural elements) are omitted for convenience. Thus, the particularshape of the device 100 and related components shown is not limiting.

FIGS. 10A-10B illustrates a front-end view of the distal end of thedevice 100 with different amounts of struts 402 and surgical instruments452. The particular shape of the distal end of the surgical instruments452 in FIGS. 10A-10B is not representative of the actual shapes of thesurgical instruments 452.

FIG. 10B shows five surgical instruments 452 attached to the struts 402in the retracted position (e.g., withdrawn into the outer sheath 102)while FIG. 11 shows the five surgical instruments 452 attached to thestruts 402 in the extended position (e.g., distally extending from outersheath 102). As shown, the surgical instruments 452 extend (e.g.,dilate) circumferentially outwards when extending distally from theouter sheath 102. This allows the canopy (or workspace) 500 to formbetween the surgical instruments 452, as shown in FIG. 11, allowing fora user to operate within the canopy 500. The particular shape of thedistal end of the surgical instruments 452 in FIG. 11 is notrepresentative of the actual shapes of the surgical instruments 452.

The device/system 100 discussed above and any or all of its componentscan be operated by a user and/or a robot (such as a robotic arm) and/ora computer. In some embodiments, certain functions can be doneautomatically. The device 100 can be used in conjunction with otherimaging equipment in some embodiments.

While the above disclosure discusses a surgical device 100 whichincludes both the labrum 300 in combination with the struts 402 formingthe canopy 500, in some embodiments these may be two separate devices.For example, an initial (or first) device can include just the outersheath 102 and labrum 300, which may or may not be retractable into thedevice. It may further include the inner module 200 discussed above.This device can allow access to a target tissue. A second device maythen include the canopy forming struts 402 in an outer sheath 102. Itmay further include the inner module 200 discussed above. Thus, thefirst device may look like FIG. 1 and the second device may look likeFIG. 7. In some embodiments, the first device may contain a lumen forthe second device to be inserted through.

In some embodiments, the same outer sheath 102 can be used for the firstdevice and the second device. For example, a first inner module cancontain the labrum 300. Once used, the first inner module can be removedfrom the outer sheath 102. A second inner module containing the struts402 can then be inserted into the same outer sheath 100. In someembodiments, the same inner module is used as well, and the labrum canbe withdrawn from the device and the struts can be inserted into them.

Method of Use

FIGS. 12-18 show an example embodiment of a method of use of the device100 in tissue 600 in order to interact with target tissue 602. FIGS.13-18 illustrate a cross-section of the device 100 for clarity.

As shown in FIG. 12, the device 100 can start outside of tissue 600. Asdiscussed above, the labrum 300 can pierce into the tissue 600, such asshown in FIG. 13. In some embodiments, the device 100 may be used via asmall percutaneous incision and/or burr hole to access a target tissue602 using navigation, direct or indirect visualization via a camera orendoscope, and/or ultrasonic probe, pressure, or LED sensor. The labrum300 (e.g., the arms 302 and needle 304) can radially open and close asthe device 100 moves through the tissue to cut and move tissue out ofthe way as the device 100 is maneuvered towards the target tissue 602.The labrum 300 can be used to swiftly penetrate soft tissue and maneuverthe outer sheath 102 to the target with minimal tissue disruption as amosquito does. In some embodiments, the labrum 300 vibrates rapidly inand out of the sheath to provide a cutting effect of soft tissue as thelabrum 300 advances, as occurs with a mosquito proboscis.

The device 100 can be steered manually or robotically through the tissue600. In some embodiments, the device 100 is steered like an endoscope.In some embodiments, the device 100 may contain pull wires for steering.In some embodiments, the device 100 may include ratcheting mechanismsfor steering.

Once at or near the target tissue 602 (e.g., upon “docking” immediatelysuperficially), the labrum 300 can be withdrawn into the outer sheath102 and/or module 200 of the device 100. Further, struts 402 can extenddistally outwards as shown in FIG. 14. The labrum 300 can be withdrawprior to the struts 402 distally extending or simultaneously with thestruts 402 distally extending. In some embodiments, the labrum 300 isnot withdrawn.

As shown in FIG. 15, the struts 402 can continue to advance bothcircumferentially outwards and distally to begin forming the canopy 500so that a user can see the target tissue 302, such as using avisualization device 202. The expanding struts 402 can further movetissue out of the way in order to form a working area in the canopy 500.

FIG. 16 shows the struts 402 in the fully expanded position forming thecanopy 500. At this time, the surgical instruments 452 may extend fromthe struts 402 in order to manipulate target tissue 602. In someembodiments, the surgical instruments 452 have previously been extendeddistally.

The surgical instruments 452 may be manipulated by a human or robotlocated at the proximal end or remotely. The surgical instruments 452may be controlled robotically via teleoperation or via autonomy, orsemi-autonomy. Teleoperation can be telefunctional in nature wherein anon-identity transformation can be present from the master to slave.Teleoperation can occur with or without haptic feedback, either duringsurgical functions or during solely user interface functions. Thesurgical instruments 452 motions may be actuated via tendon driven orconcentric tube architectures, without limitation.

FIG. 17 shows the struts 402 manipulating the target tissue 602. Thiscan include cutting, cauterizing, cooling, suction, grasping asdiscussed above. In the embodiment shown in the figures, the struts 402can form a grasping “claw” in order to remove the target tissue 602,such as if the target tissue was a tumor or other removable tissue. Insome embodiments, some of the struts 402 form the grasping claw whileothers perform other tissue manipulation.

So as to maintain tissue retraction and the canopy effect provided bythe previously described struts 402, in some embodiments only somestruts 402 (for example, only up to three or four strut instruments) mayconverge at the target tissue 602 and interact in unison orindependently at any given time on target tissue 602. These “working”struts 402 may be rigid, angled, curved or hinged. They can interactnear the center and distally to the working channel at the target zoneunder the canopy 500 provided by the “nonworking” struts. Incombination, they may be used to perform any number of surgicalfunctions based on the instrument functions listed above. This providesand maintains a visible workspace within tissue provided by the dilatoryand retraction effect of the struts used to create a surgical canopy500.

FIG. 18 illustrates the target tissue 602 withdrawn to the distal end ofthe outer sheath 102. The device 100 can then be removed from the tissue600.

If a two device embodiment discussed above is used, the first device canbe inserted into tissue to form a tunnel and withdrawn. The seconddevice (or the same outer sheath with new internal components) can beinserted into the leftover tunnel in the tissue to perform a surgicaloperation on the target tissue.

In some embodiments, the second device can fit within a lumen of thefirst device. Thus the first device can access the target tissue andonce located in the proper position, the second device can be insertedthrough the first device to perform an operation on the target tissue.

The devices, systems and methods described herein can be used to accessdeep surgical targets via percutaneous or minimally invasive corridors,including burr holes or small keyhole incisions. It can be used toremove tumors, perform biopsies, fenestrate cysts, access blood vessels(much like a mosquito), and clip aneurysms without the need for an openapproach (e.g. craniotomy) or major tissue retraction to access thetarget (e.g. brain retractors).

From the foregoing description, it will be appreciated that inventivesurgical systems are disclosed. While several components, techniques andaspects have been described with a certain degree of particularity, itis manifest that many changes can be made in the specific designs,constructions and methodology herein above described without departingfrom the spirit and scope of this disclosure.

Certain features that are described in this disclosure in the context ofseparate implementations can also be implemented in combination in asingle implementation. Conversely, various features that are describedin the context of a single implementation can also be implemented inmultiple implementations separately or in any suitable subcombination.Moreover, although features may be described above as acting in certaincombinations, one or more features from a claimed combination can, insome cases, be excised from the combination, and the combination may beclaimed as any subcombination or variation of any subcombination.

Moreover, while methods may be depicted in the drawings or described inthe specification in a particular order, such methods need not beperformed in the particular order shown or in sequential order, and thatall methods need not be performed, to achieve desirable results. Othermethods that are not depicted or described can be incorporated in theexample methods and processes. For example, one or more additionalmethods can be performed before, after, simultaneously, or between anyof the described methods. Further, the methods may be rearranged orreordered in other implementations. Also, the separation of varioussystem components in the implementations described above should not beunderstood as requiring such separation in all implementations, and itshould be understood that the described components and systems cangenerally be integrated together in a single product or packaged intomultiple products. Additionally, other implementations are within thescope of this disclosure.

Conditional language, such as “can,” “could,” “might,” or “may,” unlessspecifically stated otherwise, or otherwise understood within thecontext as used, is generally intended to convey that certainembodiments include or do not include, certain features, elements,and/or steps. Thus, such conditional language is not generally intendedto imply that features, elements, and/or steps are in any way requiredfor one or more embodiments.

Conjunctive language such as the phrase “at least one of X, Y, and Z,”unless specifically stated otherwise, is otherwise understood with thecontext as used in general to convey that an item, term, etc. may beeither X, Y, or Z. Thus, such conjunctive language is not generallyintended to imply that certain embodiments require the presence of atleast one of X, at least one of Y, and at least one of Z.

Language of degree used herein, such as the terms “approximately,”“about,” “generally,” and “substantially” as used herein represent avalue, amount, or characteristic close to the stated value, amount, orcharacteristic that still performs a desired function or achieves adesired result. For example, the terms “approximately”, “about”,“generally,” and “substantially” may refer to an amount that is withinless than or equal to 10% of, within less than or equal to 5% of, withinless than or equal to 1% of, within less than or equal to 0.1% of, andwithin less than or equal to 0.01% of the stated amount. If the statedamount is 0 (e.g., none, having no), the above recited ranges can bespecific ranges, and not within a particular % of the value. Forexample, within less than or equal to 10 wt./vol. % of, within less thanor equal to 5 wt./vol. % of, within less than or equal to 1 wt./vol. %of, within less than or equal to 0.1 wt./vol. % of, and within less thanor equal to 0.01 wt./vol. % of the stated amount.

Some embodiments have been described in connection with the accompanyingdrawings. The figures are drawn to scale, but such scale should not belimiting, since dimensions and proportions other than what are shown arecontemplated and are within the scope of the disclosed inventions.Distances, angles, etc. are merely illustrative and do not necessarilybear an exact relationship to actual dimensions and layout of thedevices illustrated. Components can be added, removed, and/orrearranged. Further, the disclosure herein of any particular feature,aspect, method, property, characteristic, quality, attribute, element,or the like in connection with various embodiments can be used in allother embodiments set forth herein. Additionally, it will be recognizedthat any methods described herein may be practiced using any devicesuitable for performing the recited steps.

While a number of embodiments and variations thereof have been describedin detail, other modifications and methods of using the same will beapparent to those of skill in the art. Accordingly, it should beunderstood that various applications, modifications, materials, andsubstitutions can be made of equivalents without departing from theunique and inventive disclosure herein or the scope of the claims.

What is claimed is:
 1. A multi-functional surgical system comprising: anouter sheath having a proximal end, a distal end, and a lumen extendingbetween the proximal end and the distal end; an inner module locatedwithin the lumen of the outer sheath, the inner module comprising aplurality of lumens extending from a proximal end to a distal end of theinner module; at least one labrum extending through at least one of theplurality of lumens of the inner module and configured to extend out thedistal end of the outer sheath, wherein the at least one labrum isconfigured to penetrate tissue and to move from a radially closedposition to a radially open position, and wherein the at least onelabrum is configured to withdraw into the inner module; and a pluralityof struts, each of the plurality of struts extending through one of theplurality of lumens of the inner module, wherein the plurality of strutsare configured to radially expand as they are advanced distally from thedistal end of the outer sheath to form a canopy working area and tocircumferentially move tissue; wherein at least some of the plurality ofstruts comprise a surgical end tip having a surgical function.
 2. Themulti-functional surgical system of claim 1, wherein the outer sheathand the inner module are flexible.
 3. The multi-functional surgicalsystem of claim 1, further comprising a camera or endoscope extendingthrough one of the plurality of lumens of the inner module.
 4. Themulti-functional surgical system of claim 1, further comprising a huband relay connected to a processor with a human or robotic interface. 5.The multi-functional surgical system of claim 1, further comprising apower source connected to at least one of the surgical end tips.
 6. Themulti-functional surgical system of claim 1, wherein the plurality ofstruts are configured to form a grasping claw while being withdrawn intothe outer sheath.
 7. The multi-functional surgical system of claim 1,wherein the at least one labrum comprises a pair of legs each having acutting surface and a needle.
 8. The multi-functional surgical system ofclaim 1, wherein the surgical end tips comprise one or more of amicrograsping forcep, a microscissors, a navigation actuatuator, amicrodissector, a cautery instrument, a suction device, a vessel clip, aligation instrument, a drug delivery device, an ultrasonic ormicrodoppler flow probe, and a spectroscopy probe.
 9. Themulti-functional surgical system of claim 1, wherein at least a portionof the at least one labrum is configured to vibrate.
 10. Themulti-functional surgical system of claim 1, wherein the system isbendable and steerable.
 11. The multi-functional surgical system ofclaim 1, wherein each of the end tips is configured to longitudinallyretract and extend within a lumen of one of the plurality of struts. 12.The multi-functional surgical system of claim 1, wherein each of theplurality of struts comprises a bend, the bend directing the strut fromextending radially outward to extending radially inwards.
 13. Themulti-functional surgical system of claim 12, wherein the bend comprisesa hinge configured to change angles.
 14. The multi-functional surgicalsystem of claim 1, wherein some of the plurality of struts do not have asurgical end tip.
 15. A method of performing surgery comprising:advancing a multi-functional surgical system having an outer sheath to atarget location with a target tissue, the advancing comprising cuttingthrough tissue with at least one labrum of the surgical system to enterthe target location, the at least one labrum extending through a lumenof the outer sheath and out a distal end of the outer sheath; distallyadvancing a plurality of struts through the outer sheath and into thetarget location, wherein the plurality of struts radially expand as theyare distally advanced out of the outer sheath to form a canopy workingarea around the target tissue, and wherein at least some of theplurality of struts includes an end effector; and performing an actionon the target tissue using at least one of the end effectors of theplurality of struts.
 16. The method of claim 15, wherein the performingthe action comprises cutting, cauterizing, dissection, clipping,ligation, drug delivery, suction, removal, or grasping.
 17. The methodof claim 15, wherein the surgical system is controlled robotically. 18.The method of claim 15, further comprising retracting the at least onelabrum into the outer sheath prior to or simultaneously while distallyadvancing the plurality of struts.
 19. The method of claim 15, furthercomprising withdrawing the plurality of struts after performing theaction, wherein the withdrawing comprises radially compressing theplurality of struts to grasp the target tissue and translate the targettissue towards the outer sheath.
 20. An assembly for a surgical system,the assembly comprising: a first surgical device comprising at least onelabrum at a distal end configured to penetrate tissue and to move from aradially closed position to a radially open position; and a secondsurgical device comprising a plurality of struts, each of the pluralityof struts being configured to radially expand as they are advanceddistally to form a canopy working area, wherein at least some of theplurality of inner struts comprise an end tip having surgicalfunctionality.